Nagakute

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 NT1. This study focuses on participants who have already been exposed to TAK-861 doses in previous clinical trials. The goal is to monitor how TAK-861 affects symptoms such as excessive daytime sleepiness and cataplexy episodes over a long period. All participants in this trial will receive TAK-861 tablets. Those who previously received a placebo will be randomly assigned to one of the TAK-861 dose groups. The study is a long-term extension conducted worldwide and is expected to last approximately five years or until the product is approved or the study is stopped. Participants may switch doses as needed and will attend multiple clinic visits, some of which can be done at home. Throughout the trial, participants will be regularly assessed for safety by tracking any treatment-emergent adverse events. Researchers will also measure changes in sleep latency, sleepiness scores, and cataplexy rates compared to baseline data from earlier trials. Follow-up assessments will take place four weeks after the final dose to monitor ongoing effects and ensure participant safety.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

Ulcerative colitis UC is an inflammatory bowel disease causing inflammation and bleeding in the colon and rectum. This trial evaluates how the drug Risankizumab moves through the body and its safety and effectiveness in treating children aged 2 to under 18 years with moderate to severe UC. The study includes about 120 pediatric participants and is sponsored by AbbVie. The trial is divided into three cohorts based on age and three substudies. In Substudy 1 SS1, participants receive a weight-based dose of Risankizumab intravenously for 12 weeks. In Substudy 2 SS2, participants are randomly assigned to one of two weight-based doses of Risankizumab given by subcutaneous injection over 52 weeks in a double-blind maintenance phase. Those completing SS2 may enter Substudy 3 SS3, a 208-week open-label extension where they receive Risankizumab based on their response. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure drug levels in the blood, clinical remission, response rates, and adverse events, with follow-up lasting about 140 days after treatment. The study aims to carefully monitor the treatment effects and safety over a long period.

Researchers are evaluating the effectiveness of a single dose of Staccato alprazolam compared with a placebo to quickly stop prolonged seizure episodes in people aged 12 years and older with stereotypical prolonged seizures. The study aims to determine if the treatment can stop seizures within 90 seconds and prevent recurrence for up to 2 hours after administration. This is a phase 3, randomized, double-blind clinical trial sponsored by UCB Biopharma SRL. Participants are randomly assigned to receive one dose of either Staccato alprazolam or placebo by inhalation during the treatment period. The study involves a parallel-group design with one treatment administration. Participants are observed for the treatments effect on seizure cessation and recurrence for up to 6 hours. During the study, participants and their caregivers will be monitored for seizure activity and safety outcomes. Various assessments include measuring treatment success within 90 seconds and seizure recurrence at 2, 4, and 6 hours after treatment. Safety is tracked through adverse event monitoring, with follow-up extending to 19 weeks after treatment. The total participation duration is based on these assessments and monitoring periods.

Researchers are evaluating linvoseltamab, an experimental drug also called REGN5458, in adults with multiple myeloma that has returned or needs treatment again after one to four prior therapies. The study compares linvoseltamab to a combination of three cancer drugs elotuzumab, pomalidomide, and dexamethasone EPd. This phase 3 study aims to assess the safety and effectiveness of linvoseltamab versus EPd in participants who have standard treatment options available and have previously received certain therapies including lenalidomide and a proteasome inhibitor. Participants are randomly assigned to one of two groups one receiving linvoseltamab by intravenous infusion, and the other receiving the EPd combination, with elotuzumab given by infusion and pomalidomide and dexamethasone given by mouth or infusion. The study focuses on how long participants benefit from the treatments, the degree of tumor response, side effects, survival, and pain improvement. During the study, participants will undergo regular assessments including disease response evaluations based on established criteria, safety monitoring, and patient-reported outcomes like pain and quality of life questionnaires. The primary measure is progression-free survival over up to about five years. Researchers will also track overall survival, adverse events, antibody responses, and other health status measures. Participation involves treatment, follow-up visits, and ongoing monitoring to understand the treatments impact.

Researchers are investigating the efficacy and safety of duvakitug in people with moderately to severely active Crohns Disease in a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. The trial includes three sub-studies aiming to evaluate duvakitugs effects compared to placebo during induction treatment phases, focusing on clinical remission and endoscopic response at 12 weeks. Participants receive subcutaneous injections of duvakitug or placebo following the study protocol. The study duration can be up to 35 weeks, including a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 open-label, Sub-Study 2 pivotal induction, or Sub-Study 3 extended induction for non-responders. A 6-week follow-up period applies to participants not entering the maintenance study. Throughout the trial, participants undergo scheduled visits for assessments including clinical remission based on Crohns Disease Activity Index and endoscopic scores. Safety is monitored with reports of adverse events and serum drug levels. Up to 8 to 15 visits are planned depending on the sub-study, with follow-up continuing for 45 days after the last dose for those not moving to maintenance treatment.

Crohns disease is a chronic inflammatory condition affecting the digestive tract and is currently incurable. This research aims to evaluate how safe and effective the drug upadacitinib is for treating moderately to severely active Crohns disease in real-world settings. The study will monitor any adverse events and track changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their own doctors according to approved local guidelines. The study plans to enroll about 240 participants in Japan who have recently started upadacitinib treatment. Treatment will follow routine clinical practice without altering the prescribed approach. Participants will be followed for up to 64 weeks with visits that may occur in person or virtually, aligned with standard care. Researchers will assess outcomes such as the percentage of participants experiencing serious infections related to the drug. There is expected to be no extra burden beyond usual medical care throughout the study period.

Researchers are evaluating the early use of empagliflozin, taken once daily by mouth, in patients hospitalized with acute heart failure who are at high risk of complications. This Phase 3, multicenter, randomized, double-blind trial compares empagliflozin to a placebo to assess its safety and effectiveness. The study is sponsored by Juntendo University and focuses on important outcomes like death, rehospitalization, worsening heart failure, and urine output within 90 days of treatment. Participants will be randomly assigned to receive either empagliflozin 10 mg once daily or a matching placebo. Treatment begins within 12 hours of hospital presentation. Both groups will be closely monitored during hospitalization and for up to 90 days after starting the study drug. The study uses a quadruple-blind design, meaning patients, caregivers, investigators, and assessors do not know which treatment is given. During the study, participants will undergo various assessments including monitoring of heart failure symptoms, urine output, blood tests for heart and kidney function, and quality of life questionnaires. Researchers will measure outcomes such as death rates, heart failure rehospitalizations, symptom changes, and kidney function over 90 days. Safety will be closely tracked throughout the study period. Total participation time varies but includes hospital stay and follow-up visits up to 90 days.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.